Manager, Commercial Quality
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Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Mumbai IndiaJob Description:
At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Description Establishes and maintains quality assurance programs procedures and controls for various elements of JJMTI Quality Management system. Knowledge and understanding of MDR2017 and D&C Act 1940 & Rules 1945 Legal Metrology. Management of Deliver (3 PL-Warehouse and Distribution) and Service & Repair activities from QMS perspective. Assist and Lead in Projects which will impact the Quality Management system of JJMTI. Ensures that performance and quality of products / services conform to established company and regulatory standards. Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems. Formulates and maintains quality assurance objectives and coordinates objectives with procedures in cooperation with other managers to assure product quality & safety. Support in the Supplier Management and monitoring and suggest improvement and ensure compliance to the Quality requirements. Reviews reports findings and makes recommendations for corrective action/preventive action/effectiveness checks. Understand and implement the Training requirements of the cross functional team members (including Commercial Quality) for performing expected tasks. Monitor and Collate metrics and update on the applicable platform in a timely manner and ensure consolidation of data for MRMs. Facilitate 3rd Party audits i.e. Notified Body FDA and other regulatory agency compliance inspections internal and suppliers audits as well as Corporate audits and coordinate responses. Escalate all significant quality issues as and when made aware of. Attend applicable training sessions as well as complete mandatory trainings on-line e-University /Learning Management Systems and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines. Required Qualification- Science Postgraduate Bio Medical Engineer Specialization in Quality Assurance Programs would be added advantage. 12-14 Years of experience in Pharma / Medical Device industry. ISO lead auditor certification (QMS) ASQ Quality Auditor certification though not a requirement would be an added advantage FDA Approval preferred. Ensure compliance of JJMI procedures to the Global Procedures and requirements and execute action based on the identified gap and create awareness on the QMS requirements amongst different stakeholders. Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Attend applicable training sessions as well as complete mandatory on-line trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines. Report any evidence of product tampering diversion and counterfeiting to the Brand Integrity function. Participate in execution of Field Action (Product Recall Distribution of Field Safety Alerts etc.) and complete the assigned tasks in a timely manner. Travelling requirement to 3 PL W&D sites Service center as applicable). Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability. Required Skills: Preferred Skills:Required Qualification and Core Competencies for the role:
Required Experience:
Manager
Key Skills
- Forecasting
- Hyperion
- Cost Management
- Construction Estimating
- QlikView
- Bus Driving
- Analysis Skills
- HubSpot
- Salesforce
- Market Research
- negotiation
- Financial Planning
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
